NONINVASIVE MEASUREMENT OF IRON BY MAGNETIC RESONANCE IMAGING (SBIR/STTR)
RELEASE DATE: October 22, 2002
RFA: DK-03-009
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
LETTER OF INTENT RECEIPT DATE: January 20, 2003
APPLICATION RECEIPT DATE: February 19, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites Small Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) applications for support of projects that have the
potential to improve the utility of magnetic resonance imaging as a method
for quantitative determinations of tissue iron, especially in liver, heart
and brain. A quantitative means of measuring body storage iron that would be
non-invasive, safe, accurate and readily available would improve the
diagnosis and management of patients with iron overload, including hereditary
hemochromatosis, thalassemia major, sickle cell disease, aplastic anemia,
myelodysplasia and other disorders. Magnetic resonance imaging potentially
provides a useful and widely available technique for examining the three-
dimensional distribution of excess iron in the body, but further research is
needed to develop a way to make measurements quantitative.
This Request for Application (RFA) must be read in conjunction with the
OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR
DISEASE CONTROL AND PREVENTION, AND FOOD AND DRUG ADMINISTRATION FOR SMALL
BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER
(STTR) GRANT APPLICATIONS (PHS 2002-2) (see
https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf)
See also NIDDK EXPANDED AWARDS FOR SBIR-AT-NIDDK
(https://grants.nih.gov/grants/guide/pa-files/PA-01-093.html)
All of the instructions within the Omnibus Solicitation apply with the
following exceptions:
o Special receipt dates
o Initial review convened by the NIDDK Division of Extramural Activities
o Additional review considerations
This RFA will utilize the Small Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR) mechanisms, but will be run in parallel
with a Request for Grant Applications of identical scientific scope (RFA DK-
03-007) that will utilize the traditional research project grant (R01) or the
exploratory/developmental (R21) grant mechanism. RFA DK-03-007 is available:
(see https://grants.nih.gov/grants/guiderfa-files/RFA-DK-03-007.html).
RESEARCH OBJECTIVES
Background
The body iron burden is a principal determinant of clinical outcome in all
forms of systemic iron overload, whether from transfusion (for thalassemia
major, sickle cell disease, aplastic, myelodysplastic, or other refractory
anemias), from increased dietary iron absorption (hereditary hemochromatosis
and other forms of primary iron overload), or both (refractory anemia with
increased ineffective erythropoiesis). Accurate assessment of the body iron
is essential for managing iron-chelating therapy in transfused patients to
prevent iron toxicity while avoiding the adverse effects of excess chelator
administration. In hereditary hemochromatosis, determination of the
magnitude of body iron stores permits identification of individuals who would
benefit from phlebotomy therapy from among those at genetic risk for the
disease.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
sponsored an international workshop on the non-invasive measurement of iron
on April 17, 2001, to assess the current state of the science and to identify
areas needing further investigation. The workshop participants concluded
that additional work was needed to develop better quantitative means of
measuring body storage iron that would be non-invasive, safe, accurate and
readily available to improve the diagnosis and management of patients with
iron overload. Currently, biomagnetic susceptometry (SQUID) provides the
only non-invasive method for measurement of tissue iron stores that has been
calibrated, validated and used in clinical studies. However, the complexity,
cost and technical demands of the liquid-helium-cooled superconducting
instruments required at present have restricted clinical access to the
method. Magnetic resonance imaging was identified as an existing, widely
available technology that, with further research, potentially could answer
that need. Among conclusions reached, the workshop participants recommended
further investigation of magnetic resonance imaging as a method for
quantitative determinations of tissue iron, especially in liver, heart and
brain. Detailed information on the workshop is available at the NIDDK
website: http://www.niddk.nih.gov/fund/other/iron/index.html
Subsequently, an article summarizing the workshop and its recommendations has
been published (Brittenham GM and Badman DG, Noninvasive Measurement of Iron:
Report of an NIDDK Workshop, Blood First Edition Paper, prepublished online
August 29, 2002; DOI 10.1182/blood-2002-06-1723;
http://www.bloodjournal.org/cgi/reprint/2002-06-1723v1.pdf)
Under physiologic conditions, the concentration of iron in the human body is
carefully regulated and normally maintained at about 40 mg Fe/kg body weight
in women and about 50 mg Fe/kg in men, distributed between functional,
transport and storage compartments. Iron overload arises from a sustained
increase in iron supply over iron requirements and develops with conditions
in which the regulation of intestinal iron absorption is altered (hereditary
hemochromatosis, refractory anemia with ineffective erythropoiesis), bypassed
(transfusional iron overload), or both. Regardless of the cause, progressive
iron accumulation eventually overwhelms the body's capacity for safe
sequestration of the excess, resulting in a variety of pathologies. The
prognosis in patients with iron overload is influenced by many factors
(Harmatz P, et. al. Severity of iron overload in patients with sickle cell
disease receiving chronic red blood cell transfusion therapy. Blood. 2000;
96:76-79.) While ferritin and hemosiderin iron almost surely are not the
species directly responsible for the adverse effects of iron, the overall
magnitude of storage iron accumulation seems to be a principal determinant of
clinical outcome in all forms of systemic iron overload.
The reference method for evaluating the extent of body iron excess in
systemic iron overload is measurement of the hepatic storage iron
concentration (Brittenham GM, et. al., Noninvasive methods for quantitative
assessment of transfusional iron overload in sickle cell disease. Semin
Hematol. 2001;38:37-56). Total body iron stores can be measured by
quantitative phlebotomy, but this approach cannot be used in transfusion-
dependent patients with iron overload and is generally acceptable only if the
procedure provides therapeutic benefit. The measurement of plasma ferritin
provides an indirect estimate of body iron stores, but the usefulness of this
measure is limited by the many common clinical conditions in which the plasma
ferritin is not a reliable indicator of body iron. While liver biopsy with
chemical analysis of tissue iron content provides the most quantitative
direct measure of iron status generally available, the discomfort and risk of
the procedure limits its acceptability to patients and precludes its frequent
use in serial observations.
Magnetic Resonance Imagining (MRI) uses the magnetic properties of the body
to provide detailed three-dimensional images of any structure or tissue. With
MRI, tissue iron is detected indirectly by the effects on relaxation times of
ferritin and hemosiderin iron interacting with nearby hydrogen nuclei. The
interactions are complex, involving factors such as tissue hydration, the
water diffusion coefficient within the tissue, the distribution of iron and
water within the tissue examined, the number of iron atoms per molecule of
ferritin and hemosiderin (called the loading factor) and, because ferritin
iron and hemosiderin iron have different effects on both T1 and T2 (Vymazal
J, Urgosik D, Bulte JW. Differentiation between hemosiderin- and ferritin-
bound brain iron using nuclear magnetic resonance and magnetic resonance
imaging. Cell Mol Biol (Noisy-le-grand). 2000;46:835-842), the relative
proportion of these two iron storage materials.
Conventional MRI measurements are affected by the instrument used, the
applied field strength, the repetition time used in the imaging sequence, the
method used to analyze the relaxation curves, and other technical aspects of
the measurement procedure. Comparison of absolute signal intensities from
one MRI unit to another is unreliable because of substantial intermachine
variation (Bonkovsky HL, et. al., Hepatic iron concentration: noninvasive
estimation by means of MR imaging techniques. Radiology. 1999;212:227-234).
In the absence of a theoretical understanding of the effects of iron on MRI,
empirical efforts to estimate hepatic iron concentrations have used a variety
of instruments, magnetic field strengths, imaging sequences (spin-echo,
gradient recalled-echo), and parameters (T1 and T2 relaxation times, and
signal intensity ratios as measured in proton, T1-, T2- or T2*-weighted
images) but no standard or generally accepted method has been adopted for
clinical application. To date, MRI has been more useful as a screening
technique for the detection of marked iron overload than as a means for
quantitative measurement. In particular, with increasing iron
concentrations, the signal intensity of the liver is reduced to such an
extent that discrimination between different concentrations becomes
impossible (Angelucci E, et. al., Limitations of magnetic resonance imaging
in measurement of hepatic iron. Blood. 1997;90:4736-4742), at least with
current technology.
Additional recent publications on both theoretical and practical efforts to
develop non-invasive methods for measurement of tissue iron are presented in
the article by Brittenham and Badman, referenced above.
Research Goals and Topics
At present, MRI provides a means of probing the three-dimensional
distribution of excess iron in the body, but further efforts are needed to
make measurements quantitative. The following are examples of basic and
clinical research that could be addressed in the application of MRI to the
measurement of tissue iron:
o improve understanding of the contribution of ferritin and hemosiderin iron
to magnetic resonance effects to guide development of optimal methods for
measuring relaxation times and susceptibility,
o improve techniques for data acquisition, choice of field strength,
selection of timing parameters, reduction of noise, identification of region
of interest and selection of analytic methods;
o devise phantoms and/or other means for calibrating and validating iron
concentration detected by magnetic resonance imaging that could enhance
standardization between different laboratories;
o develop new methods for non-invasive measurements of iron deposition in the
heart, in endocrine tissue, and in specific areas of the brain to determine
the role of abnormalities of brain iron in the pathogenesis of
neurodegenerative disorders, including Alzheimer's disease, amyotrophic
lateral sclerosis, prion diseases, mitochondrial disorders and Parkinson's
disease.
o determine whether a dual field approach, used by some for MRI measurement
of brain iron with promise of greater accuracy than conventional single-field
images, can be applied to assessment of liver iron.
o investigate the most appropriate magnetic resonance method for determining
relaxation times and susceptibility.
o determine which data acquisition method is best with selected timing
parameters.
o develop improved methods of selecting a region-of-interest.
o examine the mechanistic contribution of iron in iron-containing materials
(e.g. ferritin and hemosiderin) to magnetic resonance relaxation, to be able
to select the optimum measurement field strength and methods.
These topics are suggestions for further research, only, and investigators
are encouraged to develop and propose other lines of investigation relevant
to the purposes of the RFA.
MECHANISM OF SUPPORT
This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Future competing continuation applications
based on this project will compete with all SBIR/STTR applications and will
be reviewed according to the customary peer review procedures. The
anticipated award date is September 30, 2003.
Applications can be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants: Phase II STTR (R42) or Phase II SBIR (R44) grants; or
under the SBIR/STTR FAST-TRACK option as described in the OMNIBUS
SOLICITATION. Phase II applications in response to this RFA will only be
accepted as competing continuations of previously funded NIH Phase I
SBIR/STTR awards. The Phase II proposal must be a logical extension of the
Phase I research.
Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are
available at: https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
FUNDS AVAILABLE
The NIDDK intends to commit approximately $1,000,000 to fund five (5) Phase I
and/or Phase II applications under the SBIR/STTR set-aside funding mechanism.
Although the financial plans of the NIDDK provide support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications. At this
time, it is not known if competing renewal applications will be accepted
and/or if this RFA will be reissued.
ELIGIBLE INSTITUTIONS
Eligibility requirements are described in the OMNIBUS SOLICITATION. Any
small business, independently owned and operated by United States citizens or
permanent resident aliens, and located in the United States, may apply.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs. On an SBIR project, the principal
investigator must have his/her primary employment with the small business at
the time of award and for the duration of the project. However under the
STTR Program, primary employment is not stipulated.
SPECIAL REQUIREMENTS
In order to be responsive to this RFA, applications must focus on studies
that could lead to improved quantitative MRI measurements of body iron in
target organs (brain, heart, liver, endocrine organs) of iron overloaded
individuals. Applications addressing alternative technologies will not be
eligible for consideration and will be returned to the applicant.
Upon initiation of the program, the NIDDK will sponsor annual meetings to
encourage the exchange of information among investigators who participate in
this program, perhaps in conjunction with other related Institute-sponsored
programs. In the preparation of the budget for the grant application,
applicants should include travel funds for the one meeting each year for the
Principal Investigator and one additional senior investigator, to be held in
Bethesda, Maryland. Applicants should also include a statement in the
applications indicating their willingness to participate in such meetings.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
David G. Badman, Ph.D.
Hematology Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 621 MSC 5458
6707 Democracy Blvd.
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: db70f@nih.gov
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm.752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Aretina Perry-Jones
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 745 MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8862
FAX: (301) 480-3504
Email: ap19s@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm.752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. Please refer to Chapter VI of the PHS 398 instructions prior to
preparing a SBIR application. PHS 398 forms specific to SBIR applications are
available:
https://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc.
For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
The title and number of this RFA must be typed in Line 2 on the face page of
the application.
The OMNIBUS SOLICITATION gives the normal levels of support and period of
time for SBIR and STTR Phase I and II awards. However, these award levels
are guidelines and not ceilings. Therefore, larger budgets with longer
periods of time may be requested if required to complete the proposed
research. Projects requesting time or amounts greater than those published
in the OMNIBUS SOLICITATION must be justified strongly.
The second year of the Phase I budget should be included on the Budget
Justification page, using categorical totals if costs deviate significantly
from the first year of the budget, with narrative justifications for the
increase(s). If the second year simply escalates due to cost of living
factors, a statement to that effect with the escalation factor should be
included rather than categorical totals.
In order to apply for the FAST-TRACK option, applications for both Phase I
and Phase II must be submitted together according to the instructions for
FAST TRACK applications as described in the OMNIBUS SOLICITATION. The Phase
I application must specify clear, well-defined quantifiable milestones that
should be achieved prior to Phase II funding. Failure to provide measurable
milestones and sufficient detail may be sufficient reason for the peer review
committee to exclude the Phase II application from FAST-TRACK review. If so,
at a later date, the applicant may apply for Phase II support through normal
application procedures. Such applications will be reviewed by a standard
Study Section of the Center for Scientific Review or by a special review
group convened in response to a re-issuance of this RFA, if applicable.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and five signed photocopies, in one
package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm.752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete applications will be returned to the
applicant without further consideration. If the application is not
responsive to the RFA, CSR staff may contact the applicant to determine
whether to return the application to the applicant or submit it to compete
with other applications submitted in response to the next available receipt
date of the OMNIBUS SOLICITATION.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by NIDDK in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Diabetes and Digestive and
Kidney Diseases Advisory Council.
REVIEW CRITERIA
The review criteria for SBIR and STTR applications are found at:
https://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_SBIR
_STTR_app.htm.
ADDITIONAL CONSIDERATIONS: In addition to the above criteria, your
application will also be reviewed with respect to the following
considerations:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 20,2003
Application Receipt Date: February 19, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
For FastTrack applications, the Phase II portion may not be funded until a
Phase I final report and other documents necessary for continuation have been
received and assessed by program staff that the Phase I milestones have been
successfully achieved.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.849 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284)(or
other authorizations) and administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm (cite other relevant policies)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite
other relevant regulations).
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.